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510(k) K820044

ARTERIAL BLOOD FILTER, #AF-1025 by Bentley Laboratories, Inc. — Product Code DTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1982
Date Received
January 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class
Class II
Regulation Number
870.4260
Review Panel
CV
Submission Type

Other clearances by Bentley Laboratories, Inc.

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  • K903641 — QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q (November 9, 1990)
  • K894826 — UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF (February 28, 1990)
  • K874841 — INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (February 2, 1988)
  • K874867 — CATR(TM)-H CARDIOTOMY HOLDER (February 2, 1988)
  • K874618 — BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER (January 19, 1988)
  • K823273 — BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. (January 5, 1983)
  • K823359 — OXYGEN CONSUMPTION MONITOR #OCM-0100 (January 5, 1983)

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